Z-0655-2020Class II

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657...

Name: Z-0655-2020 Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657...
Creator: CP Medical Inc
Published: 2019-10-18
License: https://open.fda.gov/license/

Cp Medical / initiated 2019-10-18 / Open, Classified

FDA source

CP Medical Inc began a recall of Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 on 2019-10-18. FDA classified it as Class II and gives the reason as "Failed to meet USP minimum average value for knot pull (tensile) strength". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0655-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-18
Posted: 2019-12-06
Recalling firm: Cp Medical
Product: Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Failed to meet USP minimum average value for knot pull (tensile) strength.
FDA root cause: Under Investigation by firm
Action: Affected customers and distributors were contacted via email on October 18, 2019 and a follow-up certified letter was sent on October 22, 2019. Those end users not contacted by CP Medical directly will be contacted by their distributor. Please contact 470-273-6049 for recall information.
Quantity in commerce: 174 boxes 12 per box (plus 36 samples) - total of 2124 sutures
Distribution: USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE
Product codes and lots: Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0655-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0655-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-06

Product code GAM

K002190Class IIPolyglycolic Acid (Pga), Absorbable Surgical Suture (Usp)Cp Medical / cleared 2000-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)